GARDASIL:NEW INDICATION IN MALAYSIA

MSD in Malaysia announced that the National Pharmaceutical Control Bureau (NPCB) of Malaysia has approved a new indication for Gardasil in September 2010.

In addition to the current indications of Gardasil in girls and women aged 9-26 years old for the prevention of cervical cancer, vulvar and vaginal cancers and genital warts caused by Human Papillomavirus(HPV) 6,11,16 & 18, Gardasil is now also indicated in BOYS and MEN, 9 to 26 years of age, for the prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11.

Gardasil is now indicated for BOTH MALES AND FEMALES aged 9-26 years old.

ZYDENA 100mg/200mg: THE NEW PDE5I FOR ERECTILE DYSFUNCTION.

1. Zydena is the 4th therapeutic oral new drug for erectile dysfunction in the world. Zydena, which is new drug for ED, induces strong erection by selective inhibition of cGMP-specific PDE5 which is mainly presented in corpora cavernosa.


2. 88.5% of the ED subjects shows improvement of erectile function. In phase III clinical trial at 13 institutions including Seoul National University Hospital for 6 months with 270 ED subjects, 81.5%(zydena 100mg)/88.5%(zydena 200mg) of subjects showed improved erectile function in Global Assessment Question.


3. Zydena has adequate duration (8-12 hours) of drug action. In the result of clinical pharmacokinetics, Tmax of Zydena is 1 hour and T1/2 is 10-12 hours. Zydena shows high intercourse success rate even at post 8-12 hours from administration of Zydena 100mg in phase III clinical trial.


4. Its good tolerance and safety were confirmed in phase I,II and III clinical trials. the major adverse drug reactions were flushing, nasal congestion, ocular hyperaemia, headache and dyspepsia, and most of these reactions, which were reported during clinical trials, were slight and voluntarily gone with no therapy. Thus, it is confirmed that Zydena has good safety and tolerance.


5. Zydena has no inhibitory action to PDE 11 and no report has been made about myagia,back pain and testis toxicity. Zydena has no inhibitory action to PDE11, which is heteoenzyme of PDE, and no report has been made about myalgia, back pain and testis toxicity during clinical trials.